Active Pharmaceutical Ingredients

Development, Manufacturing, and Regulation, Second Edition
Herausgeber: Nusim, Stanley

• Gebundenes Buch

Produktbeschreibung

Active Pharmaceutical Ingredients

Produktdetails

• Drugs and the Pharmaceutical Sciences
• Verlag: Taylor & Francis Inc
• 2 ed
• Seitenzahl: 456
• Erscheinungstermin: 1. November 2009
• Englisch
• Abmessung: 236mm x 155mm x 25mm
• Gewicht: 764g
• ISBN-13: 9781439803363
• ISBN-10: 1439803366
• Artikelnr.: 26558244

Autorenporträt

Stanley Nusim

Inhaltsangabe

1. Introduction. 2. Process Development, Scaleup, and Design. 3. Technology
Transfer and First Manufacture. 4. Plant Design and Construction. 5.
Regulatory Requirements: US. 6. Regulatory Requirements: Outside US. 7.
Process Validation. 8. Quality Assurance and Control. 9. Environmental
Control. 10. Safety. 11. Plant Operations. 12. Bulk Sterile Manufacturing.
13. Materials Management. 14. Plant Maintenance.